It is medically well known that there are many causes of male impotence, but that one potential solution to the problem of impotence is to provide dilation of the blood vessels of the penis in order to provide an erection.
Consequently, a reliable method of providing penile vasodilation is needed. It is well known that there are a number of pharmaceutically active vasodilator materials. Among vasodilators known for producing penile erection by injection are, individually or in combination, papaverine, phentolamine, and prostaglandin E-1. A combination of the three aforementioned vasodilators is apparently preferred for medically injecting into the penis to produce erection. One such combination provides 4.4 mg Papaverine, 0.15 mg phentolamine and 1.5 mcg Prostaglandin in an injection comprising a 0.25 cc volume. Papaverine has been medically injected into a male penis for producing erection in doses from 30-120 mg.
Vasodilators thus being known for clinically producing erections, there remains to be developed a system of delivery of an effective vasodilator, such as prostaglandin, without the need for a painful injection into the male user. A system of drug delivery which has become known is the use of transdermal patches to deliver pharmaceutical materials percutaneously.
Such transdermal patches are known for assisting users to quit smoking, as with NICODERM.backslash. of Marion Merrell Dow Inc. of Kansas City, Mo. 64114 or HABITROL.backslash. of Basel Pharmaceuticals, Division of Ciba-Geigy Corp., Summit, N.J. 07901. NICODERM.backslash. is a nicotine transdermal system in which the user attaches a medication-containing patch to the skin for varying time periods over several weeks. The patches comprising the system contain medication in varying doses. HABITROL.backslash. includes a patch having an adhesive layer attached to a patch having an imbedded pad soaked with a solution of nicotine.
U.S. Pat. No. 5,124,158 of Ruwart describes transdermal antisecretory agents for gastrointestinal disease.
Such transdermal patches have advantages over oral administration of medications, in that the transdermal medication is not interfered with by gastric acids or enzymes, nor does the liver have the ability to interfere during the effective period of drug administration. Transdermal patches are generally layered structures, with the bottom-most, skin-facing layer comprised of an adhesive having microholes. Above this adhesive layer is a medication-containing layer, and a waterproof cover layer is generally provided. The adhesive serves to attach the patch to the skin and the medication in the central layer is provided to the skin through the microholes in the adhesive layer. The medication enters the bloodstream by percutaneous absorption, or, in common parlance, transdermal penetration. A further advantage of the patches is that, to an important extent, they reduce or eliminate user mistakes and forgetfulness. In addition, transdermal patches provide slow-release, measured medication over a period of time much longer than would be available if similar medication were taken orally.
Transdermal patches have been discussed for use with cancer patients ("Skin Patch Fights Cancer's Agony", USA Today, V. 120, p. 14-15, February 1992) to treat diabetics ("Skinside Out", by Deborah Erickson, Scientific American, V. 265, p. 128+, November, 1991) for cardiac patients ("Helping The Medicine Go Down-Or In", by Suzanne Wooley, Business Week, p. 84, Jan. 22, 1990; L. Gourse, "Patchwork Medicine", Science 85, V. 6, P. 79+, October 1985; Kaplan, G. "This Won't Hurt-Really", Nation's Business, V. 73, p. 25, August 1985) and to treat hormonal symptoms ("The Anti-Aging Patch for Women" Good Housekeeping, by S. Fields et al., V. 208, p. 163-164, February 1989; "Patching Up Your Health", Prevention, by Heidi Rodale, (Emmaus, Pa.) V. 40, p. 76-81, January 1988; "Hot Flash!", P. McCarthy, Health, (New York, N.Y.) V. 19, p. 29, November 1987; "More About Estrogen Skin Patches", Saturday Evening Post, (C. Servaas) V. 259, p. 52-54, January/February 1987, Newsweek, V. 107, p. 69, Jun. 30, 1986), and transdermal patches have even been discussed for use in administering cosmetics and perfume. (Corie Brown, "From Making Hearts to Winning Them", Business Week, p. 153+, Nov. 16, 1987).
In "New Way to Take Medicine", Good Housekeeping, V. 203, p. 191, August 1986, author Harriet Manley discusses the mechanism by which medication flows from the patch to the skin.
In "Transdermal Drug Delivery", Cosmetics & Toiletries, V. 106, P. 97, May, 1991, author Gary W. Cleary discusses methodology, applicable models (including the various types of transdermal patches), and the factors of importance in skin permeation.
Other literature discussing transdermal patches includes "Patching Up Drug Deliveries", Newsweek, V. 107, P. 69, Jun. 30, 1986, by M. Clark, and "New Technology Allows Medicine Without Pills", Jet, V. 69, p. 20, Jan. 20, 1986.
Nowhere in the prior art has there been a combination of a vasodilator and a transdermal patch for providing male erections, wherein the vasodilator is administered in through a selected patch which contains an edgewise peripheral impermeable boundary, or is isolated within the inside of a condom, to prevent direct contact of the vasodilator with the woman's female reproductive system. By isolating the vasodilator away from direct contact with the woman's fragile vaginal tissues, the threat of hemorrhaging within the vagina and surrounding reproductive organs is eliminated.
With this new and useful combination of elements, a third natural element in producing male erections for sexual intercourse is the well known use of condoms. Condoms are increasingly important in preventing the spread of sexually transmitted diseases, and, with the present invention, they will serve to provide enhanced, hygienic and safe sexual activity for men who otherwise are unable to have sex.
U.S. Pat. No. 2,577,345 of McEwen discloses a prophylactic condom having a reinforced cap to prevent breakage of the condom at the tip of the condom. U.S. Pat. No. 2,586,674 of Lonne discloses a prophylactic condom with reinforced annular extensions for structural integrity of the condom.
U.S. Pat. No. 3,136,417 of Clinch discloses a method of treating the surface of a condom with a lubrication oil deposited upon the surface of the condom. U.S. Pat. No. 2,600,212 of Dal Borgo describes a method of applying a layer upon a surface with the application of heat. U.S. Pat. No. 3,339,546 of Chem discloses a patch bandage in general. U.S. Pat. No. 3,677,225 of Czirely describes a shortened condom which is adhesively attached to the skin.
U.S. Pat. No. 3,998,215 of Anderson discloses a hydrogel pad attachable to the skin for electro stimulation treatment of injured body limbs. U.S. Pat. No. 4,119,094 of Micklus describes a condom which is coated for a low coefficient of friction. U.S. Pat. No. 4,274,420, U.S. Pat. Nos. 31,454, 4,306,551 and 4,307,717 of Hymes disclose substrate pads for attaching to the skin as electrodes or bandages. U.S. Pat. No. 4,354,494 of Hogin discloses a condom with an annular ring strap to hold the condom in place.
U.S. Pat. No. 4,475,910 of Conway describes a condom catheter having an adhesive to prevent leakage during urinary medical tests. U.S. Pat. No. 4,638,790, also of Conway describes a condom having an adhesive to maintain the condom in place. U.S. Pat. No. 4,415,548 of Reddy discloses a condom saturated with a spermacide solution. U.S. Pat. No. 4,640,688 of Hauser describing a urinary catheter with a pressure adhesive. U.S. Pat. No. 4,798,600 of Meadows discloses a condom with structural parts.
U.S. Pat. No. 4,869,723 of Harmon describes a condom with adhesive to hold the condom in place. Furthermore, U.S. Pat. No. 5,137,032 also of Harmon discloses a condom with adhesives to hold the condom in place.
Moreover, U.S. Pat. No. 5,137,032 of Harmon describes a condom having internally sprayed spermacide medicine, and auxiliary texturized portions to increase stimulation, but does not suggest the use of a transdermal patch within a condom, wherein the transdermal patch emits a vasodilator directly to the skin.
U.S. Pat. No. 4,829,991 to Boeck teaches a vasodilator such as nitroglycerine coated onto the inner surface of a condom for producing a penile erection. The problems with Boeck which are solved by the present invention are (1) that nitroglycerine is generally not an effective vasodilator for producing a penile erection; and (2) a major danger in using the invention of Boeck is that indiscriminate coating of the inner condom surfaces with vasodilator creates a risk of unwanted exposure of the users sex partner to the vasodilator--with potentially dangerous results for the sex partner.
With Boeck, a female sex partner could be exposed to unwanted inadvertent percutaneous vasodilator absorption if the condom ruptures or comes off during sexual intercourse. In addition, if the male condom user of Boeck's invention is not careful in applying and removing the invention, inadvertent female exposure to the vasodilator could occur.
The manner in which the present invention solves Boeck's problem of contraindicated sex partner exposure to vasodilator is to provide a transdermal vasodilator patch for a male user with or without a condom. The patch of the present invention contains the vasodilator in a sealed system, permitting it only to come in contact with the skin of the male user for desired percutaneous transdermal absorption.
Furthermore, nowhere in the prior art is there discussed the use of discreetly obscuring the view of a vasodilator patch for male erections, by secreting the patch within the condom, for example, or adhered to the skin of the male scrotum, but in any case discretely out of view from a sex partner to avoid embarrassment to the male user. Harmon also discusses adhesives for use in condoms. The adhesive can comprise any well known sticky surgical grade adhesive or other pressure sensitive adhesive known to the art, applied by any conventional means, for example as more particularly described in U.S. Pat. Nos. 4,638,790 and 4,475,910.
Additional prior art includes U.S. Pat. No. 4,254,145 of Birnbaum, which teaches the sustained protracted topical drug delivery of prostaglandin, from a transdermal bandage over a prolonged period of time, such as 24 hours, for a continuous reduction of blood pressure. The other non-prolonged drug delivery methods described in Birnbaum '145 include topical application of a cream or lotion or AQUATAIN.RTM. solution on a cotton swab, by oral capsules or injection by needle.
However, the transdermal patch of the present invention is applied immediately upon demand before sexual intercourse, such as within minutes before. Because of the spontaneous nature of sexual intercourse, in the present invention the administration of the vasodilator occurs on demand, such as in the situation of direct injections of vasodilators into a penis, as described in U.S. Pat. No. 4,127,118 of Latorre. In contrast to Latorre '118, the administration of the present invention is painless and it solves a long felt need that has existed since Latorre '118 was published in 1978.
Unlike the demand activation of the present invention, and of Latorre '118, the patch of Birnbaum '145 is delivered over a prolonged 24 hours, which is contraindicated given the spontaneity of sexual intercourse and the need for inducing erection on demand.
Furthermore, other prior art includes U.S. Pat. No. 4,573,996 of Kwiatek and U.S. Pat. No. 4,704,282 of Campbell. However, Campbell '282 is concerned with sustained, protracted release of testosterone over a prolonged period of time, such as 8-24 hours or more, that would overcome the problems associated with low overall levels of testosterone. However, neither Campbell '282 or Birnbaum '145 describe the transdermal application of a vasodilator to induce an erection upon demand before sexual intercourse.
The prior art is unsatisfactory, because the devices described therein do not have an immediate delivery on demand of a vasodilator for inducing an erection, as in Latorre '118 or in the present invention without the painful injection of Latorre '118 and priapism or possible resultant formation of scar tissue and subsequent loss of penile function.
In fact, the prolonged sustained administration of testosterone does not cause an immediate erection on demand before sexual intercourse, as it is directed to raising hormone levels, not to immediate delivery of a vasodilator to engorge penile blood vessels with blood to induce an erection.
To that end, Birnbaum '145 and Campbell '282 are directed to a composition and delivery of a particular medication for sustained, prolonged use with impotence or blood pressure irregularities. Thus, the general use of a sustained, prolonged administration of a medication, in conjunction with a transdermal patch, would be suspect as to their effectiveness or expectation of success, unless they could induce an erection on demand before sexual intercourse.
Simply using testosterone or prostaglandin in prolonged delivery whether similar or not, would therefore not provide any expectation of success.
The use of the transdermal delivered vasodilator on demand before sexual intercourse in the present invention would be discouraged, if not clearly taught away from Birnbaum '145 or Campbell '282.
Other patents concerning "on demand" use of a vasodilator to induce an erection before sexual intercourse, include U.S. Pat. No. 5,488,059 of Buhl which discloses injection of a guanidine vasodilator directly into a penis to induce an erection. Buhl '059 also mentions "transdermal application" but there is no discussion or enabling disclosure for a transdermal patch. In that sense, the word "transdermal" is equated with "topical" administration, such as direct application upon the skin of a medication. See Buhl '059 at column 2, lines 62-67.
Similarly, U.S. Pat. No. 5,270,323 of Milne describes inducing penile erections with vasodilators, but either by injection or topical transdermal delivery. However, the "transdermal delivery" in Milne '323 is topically applied to the penis or by iontophoresis, wherein an electrical current applies a solution to the skin. See Milne '323 at column 4, lines 16-24. In contrast to Milne '323, Applicant's specification at page 1, lines 9-18 discusses that a barrier is needed to avoid direction contamination by a vasodilator of the female genital tissues, with resultant bleeding problems.
While U.S. Pat. No. 5,565,466 of Gioco discusses a transdermal patch for delivery of a vasodilator to induce an erection, it was filed first on Aug. 13, 1993, which is after Applicant's first filed parent patent application filed under Ser. No. 08/069,976 on May 28, 1993.
Also, U.S. Pat. No. 5,059,603 of Rubin discloses topical administration of isoxsuprine and caffeine, and nitroglycerine and caffeine for the treatment of impotence.
However, in Rubin '603, the delivery route is described as topical administration by direct contact from squeeze tubes, spray misters, or lotions and ointments applied by cotton swabs. Rubin '603 does not disclose transdermal patches.
Except for Gioco '466, which was filed on Aug. 13, 1993 after Applicant's parent patent application of May 28, 1993, the other three patents of Buhl '059, Milne '323 and Rubin '603 all point to the need for an "on demand" method of inducing erections without contaminating the internal genital tissues of the user's sexual partner, but none of the three make the extra step of suggesting a transdermal patch.
Moreover, Latorre '118 described the need for an "on demand" method of inducing an erection, but Latorre '118 solved the problem with direct injection of a vasodilator into the penis with its attendant problems of pain, possible infection, possible scar tissue and priapism.
Additional prior art includes the orally ingested pill sold under the tradename VIAGRA.RTM., however it is an oral medication which is systemic, and has been known to cause ocular problems.
As an advancement over the solution of Latorre '118 for an "on demand" method of inducing an erection, what the present invention has done is solve a long felt need in the 19 years since Latorre '118 addressed the same problem with the aforementioned attendant problems.
Therefore the method of the present invention of applying a vasodilator from a transdermal patch for on demand use before sexual intercourse is not described or suggested by the prior art.